In a July 29, 2010 warning letter, the U.S. Food and Drug Administration (FDA) took its first enforcement action against a pharmaceutical manufacturer for its use of Facebook. Specifically, the FDA, through its Division of Drug Marketing, Advertising, and Communications (DDMAC), warned Novartis Pharmaceuticals about its advertising and sharing of product information for its leukemia drug Tasigna through Facebook Share, a social media widget on the Tasigna website. The letter follows the FDA’s November 2009 public hearings on the use of social media and demonstrates its most recent step in its slowly developing response to life sciences companies advertising and marketing products through social media.
The Tasigna Website
Novartis’ website for Tasigna contained a social media widget called Facebook Share that allowed users to share online media content related to Tasigna through their Facebook pages. First, a user could select the option to “share” Tasigna information through Facebook Share. Then, the widget would automatically generate a post, created by Novartis, for the user’s personal Facebook page. Novartis used a variety of different posts, but most included information such as the name of the drug and formulation, a product advertising-related image, a link to the Tasigna website, and a brief description of Tasigna’s uses (collectively, “posted shared content”). This content was automatically created from the metadata of the Tasigna website. This metadata, created by Novartis, is used by search engines and other programs collecting or mining online data, but it is not visible to the user of the website. Before posting or sharing the information via Facebook, the user was also able to add his or her own comment to the post,but was not able to alter any of the Novartis-generated product information in the post.
As the FDA points out in the warning letter, Tasigna’s indications changed during the time between Novartis’ initial violation through its use of Facebook Share and the date of the warning letter. When the Facebook Share widget was initially in use, Tasigna’s labeling allowed for its use in treatment of chronic phase and accelerated phase Philadelphia chromosome positive [Ph+] chronic myelogenous leukemia (CML) in adult patients resistant or intolerant to prior therapy that include imatinib. Later, the FDA expanded the approved use to include treatment of newly diagnosed chronic Ph+ CML in adults. As discussed below, although the FDA acknowledged this expanded indication, it did not impact the FDA’s final determination regarding the misleading nature of Novartis’ use of Facebook Share.
In its warning letter, the FDA identifies four specific violations by Novartis related to the posted shared content through Facebook Share on the Tasigna website, which led to Tasigna being misbranded under the Food, Drug and Cosmetic Act. These violations include: omission of risk; broadening of indication; unsubstantiated superiority claims/overstatement of efficacy; and failure to submit.
- Omission of Risk. The FDA found that the posted shared content for the Facebook Share widget failed to communicate any risk information for Tasigna. The FDA was especially concerned in the context of a drug, like Tasigna, with elevated risk and a boxed warning. And, although the FDA acknowledged that the hyperlink included in the posted shared content could guide the user to relevant risk information, it found that this alone was not a sufficient inclusion of risk information.
- Broadening of Indication. The FDA also determined that the posted shared content’s brief statement of Tasigna’s use was a misleading broadening of Tasigna’s indication because it implied that Tasigna could treat all individuals with Ph+ CML rather than just a certain subset of that population. Although the FDA acknowledged Tasigna’s recently expanded indication, it found that the statement of use would still impermissibly broaden even this additional indication.
- Unsubstantiated Superiority Claims/Overstatement of Efficacy. Further, the FDA objected to Novartis’s use of the term “next-generation” to describe Tasigna. Here, the FDA restates its previous rationale that use of this particular terminology is inherently misleading because it suggests superiority over similar products when no such superiority has been demonstrated by additional evidence or clinical experience.
- Failure to Submit. Finally, the FDA found that Novartis failed to meet its mandatory 21 C.F.R. 314.550 obligation to submit labeling and advertising information to the FDA prior to its dissemination.
The recent warning letter to Novartis is another step in the FDA’s slowly evolving response to the increased use by manufacturers of social media and Web 2.0 technology. It marks the first time that the FDA singled out Facebook and media-sharing widgets in an enforcement action. Healthcare and life sciences companies engaging in the use of any new media for product advertising and promotion should closely follow the FDA’s evolving perspective in this area and ensure that their organization has proper policies in place to stay compliant as these issues change over time.